Study of EYP-1901 in Patients With Diabetic Macular Edema (DME) (VERONA)

March 3, 2025 updated by: EyePoint Pharmaceuticals, Inc.

A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)

A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A study to evaluate Efficacy and Safety of two doses of EYP-1901 in subjects with DME

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • EyePoint Investigative Site
    • Illinois
      • Lemont, Illinois, United States, 60439
        • EyePoint Investigative Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • EyePoint Investigative Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • EyePoint Investigative Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • EyePoint Investigative Site
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • EyePoint Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of diabetes mellitus in the study eye, with disease onset any time prior to the Screening Visit
  • Previously treated with at least 1 intravitreal anti-VEGF in the last 6 months in the study eye at least 8 weeks prior to the Screening Visit.
  • BCVA letter score of 35 letters (20/200 Snellen equivalent) to 75 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).

Exclusion Criteria:

  • Any current or history of ocular disease other than DME
  • BCVA using ETDRS charts <30 letters (20/250 Snellen equivalent) in the fellow eye.
  • Active ocular inflammation or active infection in either eye at Baseline (Day 1).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aflibercept
Aflibercept 2 mg/0.05mL solution, single dose
Drug: Aflibercept 2Mg/0.05Ml Inj,Oph
Intravitreal Injection
Other Names:
  • Eylea
Experimental: EYP-1901 1343 µg
EYP-1901 1343 µg, single dose
Drug: EYP-1901
Intravitreal Injection
Other Names:
  • Vorolanib
Experimental: EYP-1901 2686 µg
EYP-1901 2686 µg, single dose
Drug: EYP-1901
Intravitreal Injection
Other Names:
  • Vorolanib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first supplemental aflibercept injection following EYP-1901 dose at Baseline vs Aflibercept
Time Frame: Week 24
Timing of supplemental injection
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in best corrected visual acuity (BCVA)
Time Frame: Week 24
Changes in BCVA
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyePoint Pharmaceuticals, Inc.

Investigators

  • Study Director: Ramiro Ribeiro, MD, EyePoint Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

October 24, 2024

Study Completion (Actual)

October 24, 2024

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYP-1901-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Macular Edema

Clinical Trials on EYP-1901

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe